Delamanid, linezolid, levofloxacin, and pyrazinamide for the treatment of patients with fluoroquinolone-sensitive multidrug-resistant tuberculosis (Treatment Shortening of MDR-TB Using Existing and New Drugs, MDR-END): study protocol for a phase II/III, multicenter, randomized, open-label clinical trial

Table 5 Definitions of treatment outcomes for patients who are drug-resistant

Cured	Treatment completed as recommended by the national policy without evidence of failure AND culture conversion after the intensive phase^a
Treatment completed	Treatment completed as recommended by the national policy without evidence of failure BUT no record of culture conversion after the intensive phase^a
Treatment failed	Treatment terminated or need for permanent regimen change of at least two anti-TB drugs because of: •Lack of conversion by the end of the intensive phase^a; or •Bacteriological reversion in the continuation phase after conversion to negative; or •Evidence of additional acquired resistance to fluoroquinolones or second-line injectable drugs; or •Adverse drug reactions
Died	A patient who dies for any reason during the course of treatment
Lost to follow-up	A patient whose treatment was interrupted for 2 consecutive months or more
Not evaluated	A patient for whom no treatment outcome is assigned (this includes cases “transferred out” to another treatment unit and whose treatment outcome is unknown)
Treatment success	The sum of Cured and Treatment completed

^aFor Treatment failed, lack of conversion by the end of the intensive phase implies that the patient does not convert within the maximum duration of the intensive phase applied by the programe. If no maximum duration is defined, an 8 months cut-off is proposed. For regimens without a clear distinction between intensive and continuation phases, a cut-off 8 months after the start of treatment is suggested to determine when the criteria for Cured, Treatment completed, and Treatment failed start to apply (for the investigational group, 6 months will be considered as an intensive phase)

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